Associate General Counsel – FDA

Pharmaceutical company seeks Associate General Counsel, FDA focusing on research and development activities. The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This attorney will work with other attorneys in the company’s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of the company’s late stage development programs. Position reports directly to the VP, Chief R&D Counsel.

Specific responsibilities may include:

• Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents

• Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges.

• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products.

• Advise Drug Safety on recent developments in risk management

• Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims.

• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments.

• JD
• 10+ years experience with global regulatory requirements in the biotechnology or pharmaceutical industry required.

• Experience with regulatory submissions, requirements and drug safety management is required.

• Experience with government affairs, FDA and EMA regulations are required.

• Must have excellent interpersonal, decision making and communication skills.